<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016082229481N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-28</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effects of appropriate nutrition education in small groups on the laboratory values in the hemodialysis patients</public_title>
      <acronym>nutrition education and laboratory values in the hemodialysis patients</acronym>
      <scientific_title>The effects of appropriate nutrition education in small groups on the laboratory values in the hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23681</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: none.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Renal Failuer Patients who need hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:&#13;
Diet training program that includes three lecture one hour in unit hemodialysis Vali asr zanjan withe use educational tools  &#13;
1. educational pamphlet proper diet supervised by a nutritionist &#13;
2. The CD contains a short educational videos for patients was conducted using computer &#13;
3. In the section with questions and answers from the patient and his entourage, the learning content taught was measured and, if necessary, further explanation was given&#13;
 All content included:  &#13;
1. kidney function&#13;
 2.failure and its complications&#13;
3. diet goals: reducing waste in the body, providing enough food for growth and repair of body, regulate body water and electrolytes (sodium, potassium, calcium and phosphorus), the prevention of anemia, and balance blood urea and creatinine &#13;
4. The list of allowed and restricted food and fluid intake body&#13;
5. how to observe proper diet and fluid intake and Complications increase urea, creatinine, sodium, potassium, calcium, phosphorus&#13;
6. finally, non-compliance by the patient's diet: the accumulation of toxins and fluids in the body, increasing the workload of the kidneys, increase the risk of disease progression, impaired physical ability, depression, malnutrition, high blood pressure and death was and else.&#13;
In three one-hour sessions in four weeks  (August) in the even-numbered days in small groups 5 members was performed. that in to six groups of five person and one groups of two person was  divided  &#13;
   &#13;
Control group: received no training and  &#13;
 routine care. Intervention 2: Control group: received no diet training and routine care.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyede Leila Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Mousavi educational and treatment center, Gavazng road, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956183</zip>
        <telephone>+98 24 3313 0000</telephone>
        <email>Mousavihospital@zums.ac.ir, SLhosseini@zums.ac</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nader Aghakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia Nursing and Midwifery School, 11 km Nazlo Road, Western Azerbaijan, Iran</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 443223489</telephone>
        <email>nader1453@umsu.ac.ir</email>
        <affiliation>West Azerbaijan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for study:&#13;
1. age 18 to 70 years&#13;
 2. No known psychiatric disorders and psychiatric treatment, according to a Psychiatrist Specializing&#13;
3. The absence of any cognitive impairment, speech or hearing &#13;
4. The lack of pain during training&#13;
5. dialysis in Zanjan&#13;
6. phone access&#13;
7. having full consent to participate in the study&#13;
8. The End-Stage Renal Disease that is constantly undergoing Hemodialysis program&#13;
 9. two to three times a week for three to four hours is treated with dialysis&#13;
10. Having read and write at least&#13;
11. sick or disabled family members are able to understand and speak the Persian  orTurkish or Azari language&#13;
12. caregivers of patients who have the greatest participation in the treatment of disease, and he spent the most time with and least education (literacy), respectively.&#13;
 Exclusion criteria:&#13;
1. Used to treat kidney transplant during the study&#13;
2. migration from dialysis during the study&#13;
3. patient died during the study&#13;
4. who frequently ill during hemodialysis and hemodialysis have not been able to afford full-time&#13;
5. The incidence of severe deterioration and the development of critical situations for each of the samples during the study&#13;
6. Not wanting to take part in a training session or a follow-up sessions during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XIV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>N18, N19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group:&#13;
Diet training program that includes three lecture one hour in unit hemodialysis Vali asr zanjan withe use educational tools  &#13;
1. educational pamphlet proper diet supervised by a nutritionist &#13;
2. The CD contains a short educational videos for patients was conducted using computer &#13;
3. In the section with questions and answers from the patient and his entourage, the learning content taught was measured and, if necessary, further explanation was given&#13;
 All content included:  &#13;
1. kidney function&#13;
 2.failure and its complications&#13;
3. diet goals: reducing waste in the body, providing enough food for growth and repair of body, regulate body water and electrolytes (sodium, potassium, calcium and phosphorus), the prevention of anemia, and balance blood urea and creatinine &#13;
4. The list of allowed and restricted food and fluid intake body&#13;
5. how to observe proper diet and fluid intake and Complications increase urea, creatinine, sodium, potassium, calcium, phosphorus&#13;
6. finally, non-compliance by the patient's diet: the accumulation of toxins and fluids in the body, increasing the workload of the kidneys, increase the risk of disease progression, impaired physical ability, depression, malnutrition, high blood pressure and death was and else.&#13;
In three one-hour sessions in four weeks  (August) in the even-numbered days in small groups 5 members was performed. that in to six groups of five person and one groups of two person was  divided  &#13;
   &#13;
Control group: received no training and  &#13;
 routine care</i_keyword>
      <i_keyword>Control group: received no diet training and routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The laboratory values BUN,Cr, Na, K, Ca, P. Timepoint: wo months before and two months after intervention. Method of measurement: five ml blood samples from patients and Biochemical reagents Company Bayvrks England.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-20</approval_date>
        <contact_name>West Azerbaijan University of Medical Sciences</contact_name>
        <contact_address>West Azerbaijan University of Medical Sciences, next to the Emergency, the end of Gahad Street, Resalat Boulvar, Urmia,Iran Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
